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CUSA® Selector®

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name
CUSA® Selector® FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Device Name
CUSA® Selector® 35 KHz Neurosurgical Handpiece FDA UDI
Model / Reference
1523000M8 FDA UDI
Description
CUSA® Selector® 35 KHz Neurosurgical Handpiece FDA UDI

Identifiers

Catalog Number
1523000M8 FDA UDI
Primary DI / UDI-DI
10381780040002 FDA UDI
510(k) Number
K021989 FDA UDI
FDA Product Code
LFL FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

CUSA® Selector® by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K021989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences (ireland) Limited

Sources (1)

  • FDA UDI 780086b7-0f5d-44af-9d19-15b007fee934 39 fields · synced Jun 1, 2026